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From Small Republics Big Ideas Grow

In a bid to expand the talent pool in its burgeoning medtech sector, Singapore has looked to the US West Coast – long regarded as a leading innovation hub in the global medtech arena – for ways to nurture a new generation of commercial-minded innovators. One such initiative is the Singapore-Stanford Biodesign (SSB) program, modelled after the renowned and successful Biodesign program at Stanford University. Tina Tan spoke to Ruey Feng Peh, director of SSB, to find out more about the program and what its outcomes have been to date.

Singapore Research and Development Innovation

EU Regulation Recap: Traceability and UDI, Registration, Eudamed And More From MDR/IVDR Chapter III

The third chapters of the Medical Devices Regulation and IVD Regulation are substantially similar in addressing UDI, and also in dealing with subjects surrounding device identification and traceability; registration of devices and of economic operators; summary of safety and clinical performance; and the European databank on medical devices (Eudamed). This is the latest in our series of articles delving into the MDR and IVDR, chapter by chapter.

Regulation Europe Medical Device

MDUFA IV Takes Shape: A Catalogue Of Draft Commitments

More specific details have emerged about the agreement "in principle" announced last week by FDA and industry negotiators on the next round of the medical device user-fee program, which will extend from fiscal years 2018 through 2022.

Regulation Medical Device In Vitro Diagnostics

Device Week – August 26, 2016

On this week's Medtech Insight podcast: many manufacturers are unprepared for US FDA's upcoming Unique Device Identification deadline; two new guidances from FDA finger benefit-risk and patient-preference issues; Fractyl Labs' Revita system shows promise in the fight against type 2 diabetes.

Regulation Medical Device Legislation
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Policy & Regulation

Set Alert for Policy & Regulation

EU Regulation Recap: Traceability and UDI, Registration, Eudamed And More From MDR/IVDR Chapter III

The third chapters of the Medical Devices Regulation and IVD Regulation are substantially similar in addressing UDI, and also in dealing with subjects surrounding device identification and traceability; registration of devices and of economic operators; summary of safety and clinical performance; and the European databank on medical devices (Eudamed). This is the latest in our series of articles delving into the MDR and IVDR, chapter by chapter.

Regulation Europe Medical Device

FDA Guidance: Industry May Use Legacy Codes Until 2021

A final guidance document issued Aug. 30 will allow manufacturers to keep using legacy codes, such as National Health Related Item Codes and National Drug Code numbers, until Sept. 24, 2021. The agency previously indicated all legacy codes should be removed from device packaging by Sept. 24, 2018, at the latest.

United States Medical Device Regulation

Latest From Policy and Regulation

Warning Letter Roundup & Recap – Aug. 30, 2016

US FDA finds quality systems and marketing violations at Texas importer of blood pressure monitors in the only warning letter released by the agency this week.

Regulation Quality Control

Hologic/Grifols, Roche Molecular Zika Tests Tapped For Blood-Screening Ramp-Up

A blood-screening test made by Hologic in collaboration with Grifols, and another made by Roche Molecular Diagnostics, are being used in a gradual ramp-up of Zika virus screening at blood donation centers across the US under a new FDA program.

Policy and Regulation United States

US FDA: Better Safety Warnings Needed On Infusion Pumps

Adverse-event reports tied to low-flow syringe infusion pumps have led FDA to recommend modifications to the pumps’ safety labeling. The agency doesn’t expect the changes to trigger a new 510(k) requirement.

Medical Device Regulation

Commercial

Set Alert for Commercial

IBA's Soaring Sales Underline Proton Therapy Demand

Ion Beam Applications continues to defend its lion's share of the proton therapy market, reporting double-digit topline growth for the first half of 2016 in spite of challenges in its more traditional radiotherapy offering.

Medical Device Cancer Commercial

Latest From Commercial

St. Jude, Short-Seller Wrestle Over Alleged Security Vulnerabilities

After Muddy Waters Research issued a report recently alleging potentially fatal cybersecurity flaws in a significant number of St. Jude's pacemakers, the research group and device-maker have been at logger-heads over the validity of the claims.

Commercial Cardiology

Alere Sues To Compel Completion Of Abbott Merger

Abbott's confidence in the planned $5.8b deal has declined since the acquisition was announced in January following disclosures of investigations into Alere's business practices. Alere hopes the suit will prod Abbott to speed its efforts to secure regulatory approvals for the merger.

Commercial Medical Device

Intuitive Sues Ethicon Over Sales Rep Non-Compete

Intuitive is suing to block Ethicon’s attempt to prevent Intuitive from hiring a former Ethicon sales rep. The device-maker says Ethicon’s attempt to enforce a non-compete agreement is void under California state law.

United States Commercial

Clinical R&D

Set Alert for Clinical R&D

Largest Sleep Apnea Trial Backs CPAP For Improving QoL, Not For Lowering Secondary Cardio Events

In the largest sleep apnea study ever conducted, continuous positive airway pressure (CPAP) did not appear to lower the risk of cardiovascular adverse events including cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina in patients with obstructive sleep apnea and known cardiovascular disease. However, patients in the trial only used CPAP a few hours a night, on average, indicating that an easier-to-use version of CPAP might yield better outcomes.

Cardiovascular Clinical Trials Research and Development

Latest From Research and Development

Foundation Adds New Markers To FoundationOne Cancer Testing Platform

The US FDA and the Centers for Medicare and Medicaid Services have already accepted FoundationOne for Parallel Review and Expedited Access for breakthrough devices. The new markers will help identify the patients who are best suited to immunotherapy or other targeted therarapies, the company says.

Research and Development In Vitro Diagnostics

MINDACT Trial: Agendia's MammoPrint Test Identifies No-Chemo Candidates

By identifying the patients at low risk for recurrence, MammaPrint could spare more than 100,000 women with early-stage breast cancer worldwide from unnecessary chemotherapy, according to Agendia.

In Vitro Diagnostics Cancer

Trial Shows InSightec's Tremor Therapy Could Improve With Better Imaging

Results of a small clinical trial of tractography-based ventral intermediate nucleus-targeting suggest this MRI-based imaging approach could help improve the outcomes of focused ultrasound brain intervention with InSightec's Exablate Neuro system for the noninvasive treatment of essential tremor.

Research and Development Neurology
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